GAIA-102 Intraperitoneal Administration in Patients With Advanced Gastrointestinal Cancer of Microsatellite Stable With Malignant Ascites
NCT ID: NCT05438459
Last Updated: 2025-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
130 participants
INTERVENTIONAL
2022-06-08
2029-03-31
Brief Summary
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Confirm the safety of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination for advanced gastrointestinal cancer of microsatellite stable with malignant ascites, and determine the recommended number of doses for Phase II part.
Phase II Part :
Research the efficacy and safety of as a monotherapy or GAIA-102 and pembrolizumab for advanced gastrointestinal cancer of microsatellite stable with malignant ascites at the recommended dose of GAIA-102 decided in the Phase I part.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GAIA-102 as a monotherapy
GAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 1 to 3 times by weekly for 3 consecutive weeks.
Phase I part
Administration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.
Phase II part
Patients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy.
For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.
GAIA-102 and pembrolizumab in combination
GAIA-102: 1 vial (2 x 10\^8 cells) as dose at a fixed dose, on 1 to 3 times by weekly for 3 consecutive weeks.
Pembrolizumab：200 mg on Day 1.
Phase I part
Administration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.
Phase II part
Patients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy.
For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.
Ttrifluridine/tipiracil hydrochloride (FTD/TPI) as the standard therapy group
Trifluridine/tipiracil hydrochloride (FTD/TPI) : Trifluridine/tipiracil hydrochloride (FTD/TPI) will be administered orally twice daily for 5 consecutive days, followed by a 2-day rest period. This cycle will be repeated twice, followed by a 14-day rest period. One course consists of this schedule, and the treatment will be repeated in cycles.
Phase II part
Patients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy.
For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.
Interventions
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Phase I part
Administration of GAIA-102 as a monotherapy or GAIA-102 and pembrolizumab in combination.
Phase II part
Patients will be randomly assigned to receive either GAIA-102 monotherapy or GAIA-102 in combination with pembrolizumab at the recommended dosing regimen confirmed in the Phase I part, or to receive standard therapy.
For patients with gastric cancer, the standard therapy group will receive trifluridine/tipiracil hydrochloride (FTD/TPI) only.
Eligibility Criteria
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Inclusion Criteria
2. Phase I:
Patients with gastric cancer who have received 3 or more prior chemotherapy regimens and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 2 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.
Phase II:
Patients with gastric cancer who have received 2 or more prior chemotherapy regimens, including at least 1 regimen containing an immune checkpoint inhibitor, and are refractory or intolerant to these therapies, and patients with pancreatic cancer who have received 1 or more prior chemotherapy regimens and are refractory or intolerant to these therapies.
3. Abdominal port placement is possible
4. No medical history of serious side effects or allergic reactions to pembrolizumab (only for patients in the pembrolizumab combination cohort)
5. Diagnosed gastric adenocarcinoma or pancreatic cancer with by histological or cytological examination
6. The patient has been confirmed to be "negative (not MSS = MSI-high)" by microsatellite instability (MSI) testing, or "proficient mismatch repair (pMMR)" by mismatch repair protein immunohistochemistry testing
7. The Eastern Cooperative Oncology Group (ECOG) performance status(PS) at the time of informed consent meets the following conditions.
* Phase I ：0-2
* Phase II ：0-1
8. Patient aged 20years or older
9. Adequate major organs (bone marrow, heart, lungs, liver, kidneys, etc.) function:
* Neutrophil ≧1,500/mm3
* hemoglobin ≧8.0 g/dL
* Platelet ≧75,000/mm3
* PT-INR≦ 1.5
* AST, ALT≦ 3 times the upper limit of reference value
* T-Bil≦ 2 times the upper limit of reference value (T-Bil ≦ 3.0mg/dL , when drainage for obstructive jaundice)
* eGFR ≧30mL/min/1.73m2
10. Expected to survive for 3 months or more at the enrollment
11. Written informed consent
Exclusion Criteria
2. Diagnosed with meningeal carcinomatosis
3. Received allogeneic hematopoietic stem cell transplantation
4. Participated in other clinical trials / clinical trials within 30 days prior to obtaining written consent and used or had used the investigational product or investigational equipment.
5. Existence or suspected active autoimmune disease
6. Continued systemic immunosuppressive therapy with corticosteroids in excess of 10 mg / day in terms of prednisolone or other immunosuppressants within 14 days prior to investigational product administration
7. Symptomatic interstitial pneumonia, or even if it is not symptomatic, it may interfere with diagnostic imaging in detecting new pneumonitis caused by the investigational product used in the clinical trial.
8. Have active double cancer and need treatment for the double cancer
9. Requires treatment as shown in "Unacceptable Combination / Supportive Therapy" during the clinical trial period
10. Have a medical history of severe hypersensitivity to immune checkpoint inhibitors or immune-related adverse events requiring treatment
11. Have one of the following complications
* Complication of cerebrovascular disorder with symptoms or history within 6 months before the enrollment
* Active gastrointestinal perforation, fistula, diverticulitis
* Symptomatic congestive heart failure
* Bleeding tendency
* Presence of blood clots that may cause embolism on the image
* Unhealed fractures (excluding compression fractures associated with osteoporosis) or severe wounds requiring medical treatment
* Uncontrollable digestive ulcer
* Active infectious diseases requiring intravenous administration of antibiotics, antifungal agents or antiviral agents
* HIV antibody positive
12. At the time of the enrollment, the period from the following prior treatment or the end of treatment has not passed.
* Surgery (including exploratory laparotomy / examination laparoscope): 2 weeks
* Palliative radiotherapy: 1 week
* Thoracic drainage: 1 week
* Pretreatment antineoplastic (from the last administration): 3 weeks
* Biopsy with incision, thoracic biopsy, treatment for trauma (excluding patients without wound healing), etc : 2 weeks
13. Scheduled thoracotomy or abdominal surgery during the clinical trial period
14. It is judged that it is difficult to enroll in this study due to clinically significant mental illness.
15. Pregnant women, lactating women, women who are currently pregnant, or have no intention of contraception for 4 months after consent is obtained.
16. Allergic to antibiotics and foreign animal-derived ingredients (pig and mouse)
17. Difficult to participate in the trial by the investigator
20 Years
ALL
No
Sponsors
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GAIA BioMedicine Inc.
INDUSTRY
Toho University - Omori Medical Center
UNKNOWN
Jichi Medical University
OTHER
Kindai University Hospital
UNKNOWN
Teikyo University Hospital
UNKNOWN
Kansai Medical University Hospital
UNKNOWN
Kyushu Cancer Center
UNKNOWN
Kyushu University
OTHER
Responsible Party
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EijiOki
Lecturer
Locations
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Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CTR024-001
Identifier Type: -
Identifier Source: org_study_id
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